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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038515
Receipt No. R000043890
Scientific Title A verification study for the suppressive effect of the test food on the elevation of postprandial blood glucose: A randomized, placebo-controlled, double-blind, crossover trial
Date of disclosure of the study information 2019/11/07
Last modified on 2019/11/08

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Basic information
Public title A verification study for the suppressive effect of the test food on the elevation of postprandial blood glucose
Acronym A verification study for the suppressive effect of the test food on the elevation of postprandial blood glucose
Scientific Title A verification study for the suppressive effect of the test food on the elevation of postprandial blood glucose: A randomized, placebo-controlled, double-blind, crossover trial
Scientific Title:Acronym A verification study for the suppressive effect of the test food on the elevation of postprandial blood glucose
Region
Japan

Condition
Condition Healthy Japanese subjects
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the suppressive effect of the test food on the elevation of postprandial blood glucose
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The incremental area under the curve (IAUC) of the blood glucose levels

* Measurement points are at before taking the test food, and at 30, 60, 90, 120 minutes after a glucose load.
Key secondary outcomes 1. The levels of maximum (Cmax) blood glucose
2. Blood glucose levels at each measurement point
3. IAUC of the blood insulin levels
4. The levels of maximum (Cmax) blood insulin
5. Blood insulin levels at each measurement point

* Measurement points are at before taking the test food, and at 30, 60, 90, 120 minutes after a glucose load.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Period I: Test food
Period II: Placebo
Carbohydrate load: "Sato No Gohan" (150 g; retort cooked rice)

* The intervention sequence is Period I to Period II, and each food is single ingestion.
* Take three tablets of the test food with water at 30 minutes before taking challenge diet (a glucose load)
* Washout period is for one week and more.
Interventions/Control_2 Period I: Placebo
Period II: Test food
Carbohydrate load: "Sato No Gohan" (150 g; retort cooked rice)

* The intervention sequence is Period I to Period II, and each food is single ingestion.
* Take three tablets of the test food with water at 30 minutes before taking challenge diet (a glucose load)
* Washout period is for one week and more.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Healthy Japanese adult subjects

2. Subjects who are judged as eligible to participate in the study by the physician

3. Subjects who are between >= 110 mg/dL and < 126 mg/dL in postprandial blood glucose, or >= 140 mg/dL and < 200 mg/dL in two-hour blood glucose in the 75 g OGTT
Key exclusion criteria 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily

5. Subjects who are currently taking medications (including herbal medicines) and supplement

6. Subjects who are allergic to medicines and/or the test food related products

7. Subjects who are pregnant, lactation, or planning to become pregnant

8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period

9. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Target sample size 34

Research contact person
Name of lead principal investigator
1st name Kazuo
Middle name
Last name YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name Naoko
Middle name
Last name SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code 112-0002
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization Toyo Sugar Refining Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel 03-5793-3623
Email info@takara-clinic.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2019 Year 10 Month 25 Day
Date of IRB
2019 Year 10 Month 25 Day
Anticipated trial start date
2019 Year 11 Month 08 Day
Last follow-up date
2020 Year 02 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 07 Day
Last modified on
2019 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043890

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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